Manufacturer
Alphatec Spine, Inc.Invictus Robotic Navigation Instruments
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Device details
FDA 510(k) registration fields
- K number
- K240951
- Device name
- Invictus Robotic Navigation Instruments
- Company
- Alphatec Spine, Inc.
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2024-04-08
- Decision date
- 2024-06-06
- Submission type
- Traditional
- Technology type
- Robotic Navigation(AI inferred)
- Clinical applications
- Spine SurgeryNavigation System
- Primary application
- Spine Surgery
- Classification source
- AI classified
Indications for Use
The Invictus Robotic Navigation Instruments are indicated for use during the placement of Invictus Spinal Fixation System screws in either open or minimally invasive procedures. The Invictus Robotic Navigation Instruments are specifically designed for use with Globus Medical's Excelsius GPS® Robotic Navigation Platform, which is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures, provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.
Intended Use
The Invictus Robotic Navigation Instruments are indicated for use during the placement of Invictus Spinal Fixation System screws in either open or minimally invasive procedures. The Invictus Robotic Navigation Instruments are specifically designed for use with Globus Medical's Excelsius GPS® Robotic Navigation Platform, which is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures, provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.
Device Description
The Invictus Robotic Navigation Instruments are surgical instruments that are designed to be compatible with Globus Medical's Excelsius GPS® Robotic Navigation Platform. The subject device is intended to facilitate the placement of screws during spinal surgery. The subject device is a reusable instrument and is offered non-sterile to be cleaned and steam sterilized by the end user.
Summary parsed at:2026-06-19 05:32:26 UTC
Predicate devices
8Cited as predicate
1Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with StealthStation)
1 submission cite K240951 as a predicate
